Sr Scientist, Functional Biocharacterization

Just is seeking a motivated and creative scientist who desires a significant opportunity to improve worldwide access to biotherapeutics. The new scientist will join a fast-paced, collaborative, and multidisciplinary team to develop and execute methods for the functional assessment and impurity monitoring of biotherapeutics. As a key member of the analytical group, the successful candidate will have significant experience in cell-based, immunoassay, and qPCR method development and qualification/validation, as well as strong experimental design and data analysis skills. Previous experience in biosimilar development, participation in CMC teams and experience authoring regulatory documents highly desirable. The ideal candidate has strong written and verbal communication skill, multitasks effectively, works well independently and in teams and is excited about ways to improve technology.

Responsibilities:

• Characterization of early and late stage biotherapeutics using diverse biological assay formats
• Method development and qualification
• Technical document authoring
• Participation in process development team(s)
• Biosimilarity and comparability assessments
• Technology transfer to Just’s Quality Control laboratory
• Technology development to improve throughput and efficiency
• Author documents to support regulatory filings
• Mentor junior staff

Required Qualifications:

• PhD with 3+ years relevant industry experience, MS with 5+ years’ industry experience, or BS with 10+ years’ experience
• Experience in the development and qualification and/or validation of release potency and impurity methods (cell-based assays, immunoassays, and qPCR)
• Experience developing and applying biological characterization methods (e.g. cell-based assays, including primary cell assays, SPR or other protein binding kinetic assays, immunoassays, etc)
• Strong oral and written communication skills
• Desire to work in a fast, collaborative, and team-oriented environment

Preferred Qualifications:

• Previous experience in biosimilar development
• Development of liquid-handling automation applications
• Experience with early & late stage regulatory filings
• Experience in technology transfer
• Experience participating in CMC teams